Uncontrolled hemorrhage from any type of wound, whether accidental or iatrogenic, may result in dire consequences. In particular, bleeding attendant with arterial damage is particularly troublesome, especially in an individual with a coagulopathy, congenital, the result of disease, or induced by administration of anticoagulants. Moreover, recovery from surgical and other procedures involving transarterial cannulation, particularly in anticoagulated individuals, presents a challenge to the medical profession as such individuals often present prolonged bleeding times from such wounds, necessitating close monitoring and increased length of hospital or in-patient stays. In such patients, manual pressure, pressure bandages, sandbags, and other means have been used to hasten hemostasis at the wound site. Not only is the excessive bleeding potentially dangerous to the patient, but the burden of the excess attention to the wound is dangerous to the already overburdened health care system.
The foregoing discussion is also pertinent to arterial and other major hemorrhagic wounds suffered from traumatic injury such as those inflicted on the battlefield, as a result of vehicular accidents, and from knife and gunshot wounds. Means to stop potentially fatal hemorrhage outside of the hospital environment is desirable.
Numerous hemostatic agents, compositions, and devices are known. Many such agents and compositions employ naturally procoagulant biopolymers, such as clotting factors and connective tissue proteins that have known hemostatic roles in vivo. Devices may include an inflatable member for blocking an opening in an artery, at which site a hemostatic agent may be introduced; other devices comprise agents or compositions in a particular form for application to a hemorrhaging site or plugging a puncture-type wound. For example, U.S. Pat. No. 5,951,583 describes lyophilized thrombin, reconstituted with buffer and mixed with collagen, to form a viscous mixture. U.S. Pat. No. 4,891,359 describes a hemostatic collagen paste composition, which optionally includes thrombin. U.S. Pat. No. 5,595,735 described a hemostatic composition comprising thrombin in a polyethylene glycol base. U.S. Pat. No. 5,948,425 described a hemostatic plug comprising collagen for sealing an incision which comprises a bleeding blood vessel. These and all other citations herein are incorporated herein by reference in their entireties.
Certain metal ions have known hemostatic properties. The use of silver nitrate as a topically applied cautery agent is known. As described in copending application Ser. No. 09/022,449, filed Feb. 12, 1998, now U.S. Pat. No. 6,245,573, metal ions such as mercuric ion, silver ion, ion, cadmium ion, copper ion, barium ion, tin ion, selenate ion and tungstate ion are useful to modulate the clotting rate of blood in order to diagnose coagulopathies. Silver metal, in the form of colloidal silver, has been used as an antimicrobial agent for many years, predating the use of antibiotics, but still used today particularly in the management of burn patients.
It is toward the development of improved hemostatic compositions and devices that the present invention is directed.
The citation of any reference herein should not be construed as an admission that such reference is available as “Prior Art” to the instant application.